Immune Checkpoint Inhibitor-Related Cytopenias: About 68 Cases from the French Pharmacovigilance Database
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Published on: February 5, 2020
Mickaël Martin1,2,3, Hoan-My Nguyen1, Clément Beuvon1,2
1Service de Médecine Interne, Centre Hospitalier Universitaire de Poitiers, 86000 Poitiers, France.
Insights
Immune checkpoint inhibitor (ICI)-related cytopenias are rare but serious conditions. This study characterized these events, finding immune thrombocytopenia and autoimmune hemolytic anemia most common, with some cases being fatal.
Area of Science:
- Hematology
- Immunology
- Pharmacovigilance
Background:
- Immune checkpoint inhibitors (ICIs) are crucial cancer therapies.
- ICI-related cytopenias are uncommon but can be severe.
- Limited data exists on the characteristics of these adverse events.
Purpose of the Study:
- To characterize immune checkpoint inhibitor (ICI)-related cytopenias.
- To analyze the incidence, types, and outcomes of these adverse events.
- To identify potential risk factors and treatment responses.
Main Methods:
- Utilized the French pharmacovigilance database for data extraction.
- Included patients with grade ≥ 2 hematological adverse drug reactions related to ICIs.
- Analyzed 75 ICI-related cytopenias from 68 patients reported up to March 2022.
Main Results:
- Immune thrombocytopenia (ITP) and autoimmune hemolytic anemia (AIHA) were most frequent (50.7% and 25.3%).
- Median onset was 2 months; nearly half were grade ≥ 4.
- Three deaths occurred due to bleeding or thromboembolic disease; 72.1% achieved remission with treatment.
Conclusions:
- ICI-related cytopenias are rare but potentially life-threatening hematologic events.
- ITP and AIHA are the most common presentations.
- Further research is needed to identify risk factors for these adverse events.
Abstract:
Immune checkpoint inhibitor (ICI)-related cytopenias have been poorly described. This study aimed to further characterize ICI-related cytopenias, using the French pharmacovigilance database. All grade ≥ 2 hematological adverse drug reactions involving at least one ICI coded as suspected or interacting drug according to the World Health Organization criteria and reported up to 31 March 2022, were extracted from the French pharmacovigilance database. Patients were included if they experienced ICI-related grade ≥ 2 cytopenia. We included 68 patients (75 ICI-related cytopenias). Sixty-three percent were male, and the median age was 63.0 years. Seven patients (10.3%) had a previous history of autoimmune disease. Immune thrombocytopenia (ITP) and autoimmune hemolytic anemia (AIHA) were the most frequently reported (50.7% and 25.3%, respectively). The median time to onset of ICI-related cytopenias was 2 months. Nearly half were grade ≥ 4, and three patients died from bleeding complications of refractory ITP and from thromboembolic disease with active AIHA. Out of 61 evaluable responses, complete or partial remission was observed after conventional treatment in 72.1% of ICI-related cytopenias. Among the 10 patients with ICI resumption after grade ≥ 2 ICI-related cytopenia, three relapsed. ICI-related cytopenias are rare but potentially life-threatening. Further studies are needed to identify risk factors of ICI-related cytopenias.
